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Nitya Surya



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    P75 - Immunotherapy (Phase II/III Trials) - Misc. Topics (ID 248)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Immunotherapy (Phase II/III Trials)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P75.12 - Prognostic Value of Neutrophil to Lymphocyte Ratio in NSCLC Patients Receiving First Line Immune Checkpoint Inhibitor Therapy (ID 3218)

      00:00 - 00:00  |  Presenting Author(s): Nitya Surya

      • Abstract
      • Slides

      Introduction

      Despite the introduction of immune checkpoint inhibitor (ICI) therapy, metastatic non-small cell lung cancer (mNSCLC) remains an aggressive and incurable disease. Programed death ligand 1 (PD-L1) expression is currently used to guide first line ICI therapies. Neutrophil to lymphocyte ratio (NLR) has recently been used as an alternative prognostic predictor in advanced cancers. This study evaluated the prognostic value of NLR and PD-L1 expression in patients treated with first line ICI therapy, either pembrolizumab monotherapy or pembrolizumab/carboplatin/pemetrexed for mNSCLC.

      Methods

      We conducted a retrospective study of patients with Stage IV NSCLC treated with a first line ICI from 2017-2020 at our institution. Baseline NLR was obtained from complete blood count within 7 days of starting treatment and was analyzed as a continuous variable. Tumor PD-L1 expression by immunohistochemistry was performed as standard of care with 22C3 antibody and reported as tumor proportion score (TPS). Median OS (95% CI) was calculated using Kaplan-Meier Survival Estimates. Cox proportional hazards model was used to examine the multivariable associations between risk factors with OS. All calculation was performed using SAS V9.4.

      Results

      Among 167 patients, 82 (49%) received pembrolizumab monotherapy with a median OS=34.5 months (95% Confidence Interval (CI):12.2 months-not reached) and 85 (51%) received pembrolizumab/carboplatin/pemetrexed with a median OS=33.7 months (95CI:14.1months-not reached). The median age of patients who received pembrolizumab monotherapy was 66.3 years [57.6, 73.1] with 36.6% female compared to 61.2 years [54.5, 66.9] with 58.1% female in patients that received pembrolizumab/carboplatin/pemetrexed. (Table 1) NLR and ECOG performance status were significant predictors of OS in a multivariate analysis of age, ECOG performance status, immunotherapy regimen, NLR and PD-L1 expression (<50% vs ≥50%). For one unit increased in NLR, the hazard of death increased by 3% (HR (95CI)=1.03 (1.01, 1.05), p=0.0004). For patients with an ECOG performance status of ≥2 the HR was 5.45 (95CI: 2.19-13.57) when compared to an ECOG performance status of 0, p=0.0003. PD-L1 expression was not a significant predictor of survival; PD-L1 expression ≥50% had a HR of 1.27 (95CI: 0.55-2.97) when compared to patients with PD-L1 expression <50%, (p=0.5758).

      Table 1: Demographic summary by type of immunotherapy
      Variable Level Pembrolizumab monotherapy (n=82)

      Pembrolizumab, carboplatin, pemetrexed (n=85)

      Total (n=167)
      Age Median [IQR] 66.3 [57.6, 73.1] 61.2 [54.5, 66.9] 62.6 [55.5, 72.1]
      Gender Female 30 (36.6%) 50 (58.8%) 80 (47.9%)
      Male 52 (63.4%) 35 (41.2%) 87 (52.1%)
      Race Asian 1 (1.2%) 1 (1.2%) 2 (1.2%)
      Black or African American 8 (9.8%) 10 (11.8%) 18 (10.8%)
      White 73 (89%) 74 (87.1%) 147 (88%)
      Histology Adenocarcinoma 54 (65.9%) 77 (90.6%) 131 (78.4%)
      Squamous 17 (20.7%) 0 (0%) 17 (10.2%)
      Other 11 (13.4%) 8 (9.4%) 19 (11.4%)
      ECOG 0 12 (14.6%) 27 (31.8%) 39 (23.4%)
      1 38 (46.3%) 48 (56.5%) 86 (51.5%)
      >=2 32 (39%) 10 (11.8%) 42 (25.1%)
      PD-L1 expression positive No 1 (1.2%) 46 (55.4%) 47 (28.7%)
      Yes 80 (98.8%) 37 (44.6%) 117 (71.3%)
      PD-L1 TPS (%) Median [IQR] 80 [60, 90] 30 [5, 50] 60 [40, 90]
      PD-L1 TPS (%) <50% 10 (12.4%) 73 (88%) 83 (50.6%)
      >=50% 71 (87.7%) 10 (12%) 81 (49.4%)
      NLR_baseline Median [IQR] 5.7 [3.4, 12.4] 8.8 [5, 13.3] 7.1 [4, 13.3]

      Conclusion

      In addition to a poor ECOG performance status, we confirmed that baseline NLR is a significant predictor of survival for mNSCLC patients who are receiving pembrolizumab monotherapy or pembrolizumab/carboplatin/pemetrexed, independent of tumor PD-L1 expression. Furthermore, NLR is an accessible test using routine blood work without imposing additional risk and cost to the patients.

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    P78 - Immunotherapy (Phase II/III Trials) - Immune Checkpoint Inhibitor Single Agent (ID 255)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Immunotherapy (Phase II/III Trials)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P78.05 - Patterns of irAE During First Line Pembrolizumab for NSCLC: Incidence, Risk Factors, and Impact on Clinical Outcome (ID 2974)

      00:00 - 00:00  |  Author(s): Nitya Surya

      • Abstract
      • Slides

      Introduction

      Pembrolizumab monotherapy is the preferred treatment option for patients with stage IV non-small cell lung cancer (NSCLC) with programmed death-ligand 1 (PD-L1) tumor expression ≥ 50% and no actionable driver mutations. There is little real word data on immune-related adverse events (irAEs) with first-line pembrolizumab. In this study, we aim to better understand irAE incidence, risk factors, and impact on clinical outcome in treatment naïve patients receiving first-line pembrolizumab therapy.

      Methods

      We conducted a multicenter, retrospective study of patients with treatment-naïve NSCLC and a PD-L1 expression of ≥50% treated with first line pembrolizumab monotherapy between June 2016 and January 2020. irAEs were determined by treating physician diagnosis and lack of alternative etiologies. Risk factors for irAE occurrence were determined using a logistic regression model. Overall survival (OS) was measured from the date of therapy initiation to death or the last point of follow-up. Survival was estimated by the Kaplan-Meier method. Cox proportional hazards were used to determine the association between irAE and OS while treating irAE as a time-dependent variable. P < 0.05 was considered significant.

      Results

      In our cohort of 153 patients, the median age was 66 years old (range 41-90); 37% of patients were female, 76.4% of patients had adenocarcinoma, and 21.5% had squamous cell carcinoma. Median follow-up time was 12 months. irAEs occurred in 65 patients (42.4%) with 23 (15.1%) developing irAE CTCAE grade ≥ 3. The most common high grade irAEs were pneumonitis (n=9), colitis (n=6), and hepatitis (n=2). Higher risk for irAE was associated with current tobacco use or cessation of tobacco use <6 months prior to treatment start (odds ratio [OR] 2.27, 95% confidence interval [CI] 1.14-4.52, P=0.02), prior or concurrent radiation therapy (OR 2.03, 95 %CI 1.06-3.90, P=0.03), neutrophil-lymphocyte ratio (NLR) >5 prior to starting therapy (OR 2.33, 95% CI 1.19-4.56, P=0.01), and longer course of pembrolizumab treatment (OR 1.039 per cycle, 95% CI 1.009-1.070, p=0.011). There was no difference in OS between patients who experienced low grade irAEs (<3) and those who did not develop irAEs (HR=0.391, 95% CI 0.124-1.231, p=0.1325) while those who developed high grade irAEs (≥ 3) had worse OS (HR 2.419, 95% CI, 1.117-5.243, p=0.021). Of patients who developed any grade irAEs, those who discontinued pembrolizumab therapy after irAE were found to have worse OS than those who continued therapy (HR 3.178, 95% CI 1.14-8.83, p=0.03).

      Conclusion

      Risk factors for the development of irAEs during first-line pembrolizumab included current or recent smoking status, NLR >5 prior to treatment start, prior or concurrent radiation therapy, and longer exposure to therapy. Higher grade irAEs and those events leading to discontinuation were associated with worse OS, and no OS benefit was observed in patients with lower grade adverse events. Our study identifies patients at high risk for irAEs who may benefit from closer monitoring during therapy. The lack of survival benefit from irAE in NSCLC patients with high PD-L1 expression has not previously been reported and warrants further investigation.

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